EcoAnaesthesia Facemask Versus Standard Facemask During Anesthesia Induction
Study Details
Study Description
Brief Summary
This study will evaluate the efficiency of the EcoAnesthesia mask and its advantages over the standard facemask used in our practice. The satisfaction by the anesthesia provider and its ease of use may change the standard practice in airway management. In addition to these additional effects on patient safety, the facemask is affordable and may reduce the environmental burden of anesthesia waste.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: EcoAnesthesia Mask first Both the "standard adult facemask" (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. This group will receive the EcoAnesthesia Mask first. |
Device: EcoAnaesthesia facemask first
The trial facemask will be used before the standard one.
Device: Portex Adult (Standard) facemask second
The standard facemask will be applied after the trial device
|
| Active Comparator: Standard mask first Both the "standard adult facemask" (Portex Adult, USA) and the new facemask (EcoAnesthesia Mask, Intersurgical, Inc., Liverpool, NY, USA) will be tested in each patient for three minutes. The order of usage of each mask will be randomly assigned to each patient. Patients in this arm will receive the standard mask first. |
Device: Portex Adult (Standard) facemask first
The standard facemask will be applied before the trial device.
Device: EcoAnesthesia facemask second
The trial facemask will be used after the standard one.
|
Outcome Measures
Primary Outcome Measures
- End-tidal oxygen concentration [three minutes]
End-tidal oxygen concentration after 3 minutes with the mask that the patient was first randomized to use.
Secondary Outcome Measures
- Maximum airway pressure [End of 3 minutes with each mask]
Maximum airway pressure, which will be necessary to reach a tidal volume of at least 6 ml/kg every minute during the 3 minutes of mask ventilation with each device.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ASA physical status class 1-2
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Undergoing elective surgery
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Aged between 18 and 75 years
Exclusion Criteria:
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Severe acute or chronic lung disease requiring oxygen-therapy;
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Hiatus hernia with gastro-esophageal reflux or other esophageal or gastric abnormalities that require a rapid sequence induction;
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Food intake within the last 6 hours or clear fluid intake within 2 hours prior to surgery;
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Ischemic or congenital heart disease;
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Pregnancy (confirmed by a pregnancy test);
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Patient is scheduled for regional anesthesia and denies conductance of general anesthesia during the surgical procedure;
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Known difficult intubation in the past.
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Difficult Mask Ventilation. Patients having any two of the criteria listed below will be Categorized as "Difficult Mask Ventilation (DMV)" (5,13,14) and will be excluded from enrollment. All others will be classified as "Normal." Age > 55 BMI > 26 kg/m2 Lack of teeth Presence of beard History of snoring Limited mandibular protrusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Louisville Hospital | Louisville | Kentucky | United States | 40202 |
Sponsors and Collaborators
- University of Louisville
Investigators
- Principal Investigator: Detlef Obal, MD, University of Louisville
Study Documents (Full-Text)
None provided.More Information
Publications
- UoL IRB 09.0588